NCT05850728

First in Human Study of TLC-ART 101 (ACTU 2001)

First in Human Clinical Trial of a Next Generation, Long-acting Injectable, Combination Antiretroviral Therapy Platform

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.

Detailed description

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study has two primary aims as follows: 1. To characterize the plasma concentration-time course and pharmacokinetics (PK) of a single dose of the drug substances of TLC-ART 101 (lopinavir, ritonavir, and tenofovir) administered by subcutaneous injection within the drug combination nanoparticle. 2. To characterize the safety and tolerability of a single subcutaneous injection of TLC-ART 101. There are 4 exploratory mechanistic objectives (with related endpoints) as follows: 1. To characterize the pharmacokinetics of the drug substances in human peripheral blood mononuclear cells (PBMCs) 2. To characterize the concentrations of intracellular TFV-diphosphate (the active moiety of TFV) in PBMCs 3. To explore whether the pharmacokinetic parameters of the 3 drug substances differ by sex following a single dose 4. To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101.

Conditions

• Human Immunodeficiency Virus
• Treatment
• Antiretroviral Therapy

Interventions

Type	Name	Description
DRUG	TLC-ART	TLC-ART 101 contains lopinavir, ritonavir, and tenofovir in a combination nanoparticle suspension

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2023-05-09
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study